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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00621361 |
This study is to assess the safety and tolerability of Cediranib (RECENTIN™, AZD2171)in combination with etoposide and cisplatin (EP) as first line treatment for lung cancer patients with extensive stage or metastatic disease for whom EP would be a standard therapy.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: AZD2171 Drug: Etoposide Drug: Cisplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Multi-Centre, Open-Label, Dose Selection Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Etoposide and Cisplatin (EP) as First Line Therapy for Lung Cancer Patients With Extensive Stage or Metastatic Disease for Whom EP Would be a Standard Therapy |
Estimated Enrollment: | 25 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: AZD2171
Oral
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2: Active Comparator
Etoposide + Cisplatin
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Drug: Etoposide
Intravenous
Drug: Cisplatin
Intravenous
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: AstraZeneca Cancer Locator Service | 877-400-4656 | astrazeneca@emergingmed.com |
Contact: AZD2171 Trials | AZD2171trials@astrazeneca.com |
United States, California | |
Research Site | Recruiting |
Sacramento, California, United States | |
United States, Colorado | |
Research Site | Recruiting |
Denver, Colorado, United States | |
United States, Kansas | |
Research Site | Recruiting |
Kansas City, Kansas, United States | |
United States, Texas | |
Research Site | Recruiting |
Houston, Texas, United States |
Principal Investigator: | John Heymach, MD | M.D. Anderson Cancer Center |
Responsible Party: | AstraZeneca ( Jane Robertson, Medical Science Director ) |
Study ID Numbers: | D8480C00054 |
Study First Received: | February 12, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00621361 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lung Cancer AZD2171 cediranib |
RECENTIN etoposide cisplatin |
Thoracic Neoplasms Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Neoplasm Metastasis Antineoplastic Agents, Phytogenic Etoposide phosphate Etoposide |
Thoracic Neoplasms Respiratory Tract Neoplasms Antineoplastic Agents Physiological Effects of Drugs Etoposide phosphate Pharmacologic Actions Neoplasms Neoplasms by Site |
Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Lung Diseases Therapeutic Uses Antineoplastic Agents, Phytogenic Etoposide |